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Community Home-based Care Intervention and Its Health Outcome in HIV-positive People (HIV)

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ClinicalTrials.gov Identifier: NCT03505866
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Tokyo University
Information provided by (Responsible Party):
Khem Narayan Pokhrel, Integrated Development Foundation Nepal

Brief Summary:
An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at the home of HIV-positive people. The intervention started in March, 2018 and completed in August 2018. The major measurements of the interventions were ART adherence, status of depression, anxiety, and stress levels.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Depression Stress Anxiety Quality of Life Behavioral: Community home-based care intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The intervention was started in February and March, 2015 and was completed six month later. The program comprises of psychosocial support/peer counseling, ART adherence support and counseling, basic health care, and referral for further care. The support team comprises of a community health worker, a trained HIV-positive person, and a social worker.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigating the Impact of Community Home-based Care Intervention on Mental Health Outcomes and Anti-retroviral Therapy Adherence in People Living With HIV
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : August 31, 2015
Actual Study Completion Date : August 31, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Mutual support groups of HIV
HIV-positive people who did not enroll in a community home-based care intervention and receiving regular HIV services and support from mutual support groups of HIV
Behavioral: Community home-based care intervention
HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.




Primary Outcome Measures :
  1. Depression [ Time Frame: 6 months ]
    Depression was measured using a Center for Epidemiologic Studies Depression (CESD) scale. This scale consists of 20 items that are designed to measure the participant's experience of depressive symptoms in the past week of data collection. The total scores range from 0 to 60, and, a cut off point was set as scores ≥ 16 designating the occurrence of depressives symptoms.

  2. Anti-retroviral therapy non-adherence [ Time Frame: 6 months ]
    Adherence to anti-retroviral therapy was measured using AIDS Clinical Trial Group Questionnaires. The questionnaires are designed to measure non-adherence whether the HIV-positive person missed at least one dose of anti-retroviral therapy in the past month of the data collection. The questionnaire assess

  3. Anxiety [ Time Frame: 6 months ]
    Anxiety was measured anxiety using Composite International Diagnostic Interview Short-Form (CIDI-SF) the scale use nine screening stem questions that were designed to measure the episodes of anxiety and their control over their worries and anxious state.

  4. stress [ Time Frame: 6 months ]
    Stress was in the past month using the Perceived Stress Scale (PSS). It consists of 10 items with scores ranging from "0" (never) to 4 (very often). The total score ranges from 0-40. Higher stress scores indicate high level of stress.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. HIV-positive people who did not enroll in a community home-based care program before the baseline data collection for intervention. Those who were referred by an ART center or a voluntary counseling and testing center for care and support services
  2. Those who were diagnosed as HIV-positive within five years of baseline data collection and living in the selected districts for at least one year
  3. Those who received pre-ART counseling services and were receiving ART for at least one year
  4. Those who voluntarily agreed to enroll in a community home-based care program and received intervention after the baseline study.

Exclusion Criteria:

The exclusion criteria were being hospitalized for an intensive care at the time of data collection


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Khem Narayan Pokhrel, Research and Program Development Advisor, Integrated Development Foundation Nepal
ClinicalTrials.gov Identifier: NCT03505866     History of Changes
Other Study ID Numbers: 1523
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Khem Narayan Pokhrel, Integrated Development Foundation Nepal:
HIV
Anti-retroviral therapy
Intervention
Mental Health

Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents